Trial regulatory services

Regulatory Services

Our regulatory services for pharmaceutical and biotech industries include:

• Regulatory strategy and development planning
• Preparation of applications, documents and translations
• Competent Authority and Ethic Committee submissions and communication
• Regulatory/GMP Compliance
• EU legal representation

Regulatory Submissions to Competent Authority and Ethical Committees

Our regulatory experts provide strategic insight to optimize your product’s success.

COUNTRY SELECTION and local regulatory consultancy and timeline guidance.

LIAISON with local regulatory authorities, EMA, Institutional Review Boards, and Ethics Committees in EU countries.

PREPARATION of clinical trial authorization applications.

CREATION, preparation, execution and maintenance of regulatory documents for submission to industry sponsors, ethics committees, and regulatory authorities.

EU Legal Representation

Under the terms of the 536/2014 Regulation in order to conduct clinical trials in the European Union, non-EU-based sponsors must have a European company as their legal representative.

We offer a contract with non-EU sponsors to provide the required legal representative, including the responsibilities of the sponsor with regards to GCP and regulatory compliance.